MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE MOBILE POWER UNIT, NA; VENTRICULAR (ASSIST) BYPASS

Model Number 107754

Device Problems Failure to Power Up (1476); Complete Loss of Power (4015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2022

Event Type  malfunction  

Event Description

It was reported that the patient's mobile power unit (mpu) sparked and shut off.The patient switched to a second mpu and it did not work either.The patient then switched to battery power and the alarms resolved.The black cord was exchanged which made no difference.A loaner mpu was given and the alarms resolved.Related mfr # 2916596-2022-12117.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the mobile power unit not supplying power was confirmed.The mobile power unit (mpu) (serial number: (b)(6)) was returned for analysis to the service depot with a kink in the patient cable of the mpu.The mpu was evaluated and tested on 25aug2022.The mpu was connected to ac power and did not power on confirming the reported event.The mpu¿s patient cable was then manipulated near the kink area and a yellow wrench would momentarily appear on the mpu.The cable was replaced with a known functional patient cable and the mpu was able to function normally.All other components were found to be in good condition.The mpu was forwarded to the product performance engineering (ppe) lab for further analysis.The returned mobile power unit was connected to a test system controller and mock loop.Upon powering on the mpu, a yellow wrench began flashing.The insulation of the underlying was tested, and the yellow and gray wires were found to have an open loop indicating that they were shorting to the shield of the cable.A test patient cable was inserted into the mpu and the mpu functioned as intended.The outer jacket was removed, and damage was observed to the yellow and gray wires.The device history records were reviewed and the records revealed the mobile power unit (serial number: (b)(6)) was manufactured in accordance with manufacturing and quality assurance specifications.The customer order was shipped on 14dec2020.Heartmate iii instructions for use (rev.C) section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook (rev.D) section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE MOBILE POWER UNIT, NA
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15058150
• MDR Text Key: 303824716
• Report Number: 2916596-2022-12118
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: 00813024010883
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 107754
• Device Catalogue Number: 107754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic